Venclose digiRF Generator (VCRFG1)— 510(k) K250068

Name: FDA 510(k) clearance K250068
Creator: U.S. Food and Drug Administration
Published: 2025-02-04

Substantially Equivalent

Venclose, Inc.

FDA 510(k) clearance K250068 for Venclose digiRF Generator (VCRFG1), Substantially Equivalent on 2025-02-04. Applicant: Venclose, Inc.. Device class: 2.

Clearance details

Applicant: Venclose, Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2025-01-10
Decision date: 2025-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K250068

K-number listed on FDA's recall record

Z-2638-2025 — Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).Class II·Ongoing·Bard Peripheral Vascular Inc·20250821

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K250068.

Data sourced from openFDA. This site is unofficial and independent of the FDA.